Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
340B Drug Pricing Program Compliance
Inflation Reduction Act’s Drug Price Negotiation Provisions – What Now? – Diagnosing Health Care Podcast
Podcast: Inflation Reduction Act’s Drug Price Negotiation Provisions – What’s Next? - Diagnosing Health Care
Podcast: Chevron Deference: Is It Time for Change? - Diagnosing Health Care
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Podcast: IP(DC): Drug Prices, Political Pressures & Patents
Drug Pricing Initiatives During the Trump Presidency
K&L Gates Triage: An Insider’s Perspective on the Health Care Debate in Washington, DC
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
K&L Gates Triage: 340B Eligibility - Hospital Covered Entities
Measures of success: How value-based pricing may change the pharmaceutical industry
The Centers for Medicare & Medicaid Services (CMS) on Sept. 20, 2024, released the Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434) Final Rule....more
In this episode of Wiley’s Health Care Contracting Chronicles, hosts Jordan Ross and Brooke DeLoach introduce the complex world of Pharmacy Benefit Managers (PBMs) and their pivotal role in the healthcare industry. They...more
As prescription drug costs remains a significant, and largely bipartisan, issue for state and federal legislators, we continue to see activity focused on pharmacy benefit managers (PBMs) as we approach the last quarter of...more
The 340B Drug Pricing Program continues to provide critical support for covered entities, although the program is subject to ongoing scrutiny and congressional, judicial, and industry pressures. Certain key guidance documents...more
As we enter into the final months of 2024, new developments in the administration of the 340B Drug Pricing Program signal that additional reform may be on the way. Although recent revisions to the 340B program’s...more
On August 23, Johnson & Johnson (J&J) issued a written notice to disproportionate share hospitals that participate in the prescription drug discount program established under section 340B of the federal Public Health Service...more
While audits are part of doing business in the ordinary course, businesses are generally less than eager to open the books. And the same is true when it comes to the 340B Drug Pricing Program. Audits are now making the list...more
As we have previously reported, the Inflation Reduction Act (IRA) changed the government’s treatment of certain prescription drugs under the Medicare program by directing the Secretary of Health and Human Services (HHS) to...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-07 (the “Opinion”), to a nonprofit tax-exempt grant-making...more
On August 15, 2024, the Centers for Medicare & Medicaid Services (CMS) released the first set of negotiated prices for the Medicare Drug Price Negotiation Program for 2026. Authorized under the Inflation Reduction Act of...more
News Briefs - Statistics Show Upward Trend in Healthcare Data Breaches - Healthcare data breach statistics clearly show there has been an upward trend in data breaches over the past 14 years, with 2021 seeing more data...more
On August 21, Oregon’s Prescription Drug Affordability Board (PDAB) reviewed a draft upper payment limit (UPL) constituent engagement report, which captured feedback from patients, providers, health plans, manufacturers, and...more
News Briefs - Physicians Responsible for Meeting CMS Information Blocking Rules - The Centers for Medicare & Medicaid Services and Office of the National Coordinator for Health Information Technology issued a final rule that...more
A new litigation trend is emerging regarding fiduciaries of health plans and their duties to prudently evaluate fees being charged by pharmacy benefit managers (“PBM”). Two Fortune 50 employers, Johnson & Johnson and Wells...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
On August 9, Maryland’s Prescription Drug Affordability Board (PDAB) released its draft action plan for establishing upper payment limits (UPLs) for drugs identified as causing or likely to cause affordability challenges. The...more
News Briefs - State Governments Taking Steps to Make Rules on Healthcare AI - In the absence of federal guardrails on artificial intelligence in healthcare, state governments are figuring out their own rules of the road....more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
In this podcast, explore how health insurance companies are adapting to the Inflation Reduction Act's new requirements, including the Part D redesign. The US healthcare landscape is undergoing significant changes as the...more
As many have now heard, on Thursday, August 15, 2024, the Centers for Medicare & Medicaid Services (CMS) released the prices for the first 10 prescription drugs selected for negotiation with manufacturers (Selected Drugs)...more
On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more
The Centers for Medicare & Medicaid Services (CMS) is required to make public by September 1 the “maximum fair prices” (MFP) that CMS is setting for the first ten drugs subject to the Medicare Drug Price Negotiation Program...more
CMS Finalizes New TCET Pathway. The final procedural notice, effective immediately, creates a new pathway that uses existing national coverage determination and coverage with evidence development (CED) processes to expedite...more
On July 31, the Centers for Medicare and Medicaid Services (“CMS”) published its mammoth proposed rule entitled “Medicare and Medicaid Programs: Calendar Year 2025 Payment Policies under the Physician Fee Schedule and Other...more